Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes

Last updated: May 27, 2025
Sponsor: Region Örebro County
Overall Status: Terminated

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

Heel cream

Sock of silicone

Clinical Study ID

NCT02641548
OLL-524811
  • Ages > 18
  • All Genders

Study Summary

This study evaluates the addition of using a sock of silicone to using a heel cream, in the treatment of heel fissures in people with diabetes, aiming at healing the fissures and preventing them from developing into ulcers. Half of the participants will use the silicone sock and a heel cream, the other half will use the cream only.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diabetes diagnosis, and

  2. Deep heel fissures

Exclusion

Exclusion Criteria:

Factors associated with increased risk of complications:

  1. known allergy or hypersensitivity to silicone or ingredients in cream

  2. other skin conditions that make use of sock or cream inappropriate

  3. strongly fluctuating foot edema

  4. ulcer in part of the foot that the sock is in contact with

  5. inability of participant or assisting person to handle the silicone sock correctlyincluding daily cleaning.

Factors associated with increased risk that complications are not discovered or reported, such as, dementia, language or other communication impairments, intellectual disability or known substance abuse, AND there is no other person who can provide adequate support to the participant.

Study Design

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: Heel cream
Phase:
Study Start date:
February 18, 2016
Estimated Completion Date:
April 01, 2019

Study Description

Dry skin and heel fissures are common complications of diabetes and can develop into hard-to-heal ulcers that eventually can make amputation of the foot necessary.

Patients are advised to use heel creams to heal fissures and prevent them from developing into ulcers. Clinical observations have suggested that wearing a silicone sock nighttime can heal fissures, but the additional advantage of using a silicone sock compared to use a heel cream only has not been investigated.

Participants will be randomized to an intervention group (silicone sock and heel cream) or a control group (heel cream only) and the healing of fissures and development of new ulcers will be compared between the groups.

Connect with a study center

  • Örebro University Hospital

    Örebro,
    Sweden

    Site Not Available

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